ENTREVESTOR: P.E.I. firm gains traction with drug

Denis Kay has been a scientist for a long time, but he’s most thrilled by his current role working on a promising drug for Alzheimer’s disease.

Alzheimer’s is an escalating problem in aging societies. It’s estimated that the worldwide annual market for Alzheimer’s drugs is already $3.8 billion, although the cost to society is far greater.

“Sometimes I can’t sleep at night because of my excitement over the drug and working for a small biotech venture,” said Kay, who is a founder and chief scientific officer of Charlottetown’s Neurodyn Life Sciences.

Kay is energized because Neurodyn’s Alzheimer’s drug, Memogain, has obtained test results that show it boosts cognition.

In recent clinical trials, Neurodyn tested Memogain on both young and elderly healthy volunteers.

Both groups showed improved working memory.

Memogain is an improved version of a drug called Galantamine. Galamantine is also a substance derived from snowdrop plants and daffodils, and has historically been used as a memory aid in northern Europe.

Memogain’s original developer, Dr. Alfred Maelicke, working in Germany, was a leader in the clinical development of Galantamine as a prescription medicine for the treatment of mild-to-moderate Alzheimer’s disease.

Neurodyn bought Memogain from Maelicke’s company, Galantos Pharma, last year after the 2008 financial crash left his group unable to raise the funds needed to continue developing the drug.

Maelicke had recognized that an improved version of Galantamine could be developed by adding a simple acid to the original drug. This is what Neurodyn has in clinical development.

The addition of the acid increases the drug’s ability to pass through the blood-brain barrier and decreases its gastrointestinal side effects.

The blood-brain barrier protects the brain from dangerous substances in the blood. It’s so effective that it presents an enormous problem when drugs need to be delivered directly to the brain.

Kay said pre-clinical development suggests the new drug is at least 10 to 15 times better at penetrating the blood-brain barrier than the parent drug.

He said most Alzheimer’s drugs ameliorate the disease for just one year, but he thinks the improved Memogain may work longer.

“(It) allows dosing to much higher levels. We will be able to dose with at least 10 times as much drug, possibly as much as 50 times more.

“Also, our tests on rats, whose brains function very similarly to humans, suggest that at sufficiently high concentrations, the drug increases the creation of new brain cells, leading to increased cognition and memory.”

He said that other, independent pre-clinical tests have shown that Memogain decreases the amount of damaging amyloid plaques found within diseased brains.

Now, plans are underway to test the drug in a patient population.

The company will soon be talking to the European Medicines Agency, the Food and Drug Administration in the United States and Health Canada about the time frame through which the drug may be brought to market.

“The most optimistic estimate is three years for market approval,” Kay said. “Europe will probably be the first to approve it.”

He added that it may be possible to obtain up to 10 per cent of the Galantamine required to make Memogain for the worldwide market from daffodils grown in Atlantic Canada.

Kay published his first peer-reviewed work in 1976 as an undergraduate science student at Dalhousie University. Working on Memogain is the highlight of a career that has seen him tackling other diseases that affect the brain and nervous system, such as AIDS and amyotrophic lateral sclerosis.

“Around 96 to 98 per cent of the burden of Alzheimer’s lies in patient care,” he said. “We believe we’re going to improve the lives of patients and their families in an affordable way.”